Kornimate/medical-research-clean huggingface dataset:
evaluate the safety and efficacy of phenazopyridine hydrochloride tablets, usp 200 mg vs. placebo

Conditions: Pain; Urinary Tract Infections

Summary: this study will evaluate the safety and efficacy of phenazopyridine hydrochloride tablets, usp 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine associated with uncomplicated urinary tract infections (uuti)


Eligibility criteria:
inclusion criteria: * diagnosis of uncomplicated urinary tract infection (uuti) * must have one of the following uuti diagnosis * cystitis * urethritis * a positive urine dipstick test showing nitrate or leukocyte esterase (le) * negative pregnancy test (if applicable) * must have one or both of the following symptoms of * pain upon urination * burning upon urination * in addition, one of the following symptoms * not being able to empty bladder completely * pain or discomfort in lower abdomen, or pelvic areas * frequent urge to urinate * blood in urine * none exclusion criteria: * any diagnosis of a urinary tract or kidney disorder that is not a uuti * a diagnosis of pyelonephritis (kidney infections when lower uuti spreads to the upper tract) * women with a history of prior use of phenazopyridine hydrochloride * women who have taken any systemic anti-infectives within seven days of study participation * women with a history of g-6-pd deficiency or hemolytic anemia * women who have a known history of anatomical genitourinary (gu) anomalies or gu surgery within the past 6 months * women of child bearing age who do not consent to a pregnancy test * women who are lactating * chronic infection of the urinary tract requiring an intravenous pyelogram (ivp), ultrasound or cystoscopy * subjects with clinically significant abnormal results or finding on the screening physical examination, laboratory tests, vital signs or ecg. * subjects unable to comprehend the language of the informed consent and the self evaluation scales. * subjects with serious acute illness (e.g. pneumonia) or an untreated or unstable medical illness that would likely interfere with assessments of uuti * subjects who have received an investigational medication as part of a drug trial 3 months prior to the baseline study visit * subjects with a history of severe drug allergy or hypersensitivity * subjects with a known sensitivity to phenazopyridine, hyoscyamine, butabarbital and antibiotics. * employees of the investigator or the institution who have direct involvement in the trial or other trials under the direction of the investigator or their associates.

Keywords: uuti pain or burning associated with uncomplicated urinary tract infections
poor in vitro fertilisation outcomes in genital tuberculosis - case report

Conditions: Tuberculosis, Female Genital; Fertility Disorders

Summary: this is a case series that highlights the challenges in instituting in vitro fertilisation (ivf) treatment amongs genital tuberculosis patients.

in this case series, the investigators recruited patients undergoing ivf treatment previously diagnosed with tb between 01/01/2014 and 30/06/2021. patients were recruited at the beginning of their ivf treatments. total sampling was employed for this study.

Eligibility criteria:
inclusion criteria: * patients with confirmed genital tuberculosis enrolling in in vitro fertilisation treatment exclusion criteria: * patients not confirmed to having genital tuberculosis

Keywords: in vitro fertilisation genital tuberculosis
study of su011248 in combination with docetaxel and trastuzumab in patients with advanced breast cancer her-2 positive

Conditions: Breast Cancer

Summary: this is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of su011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing her-2, who have not received chemotherapy treatment in the advanced disease setting.


Eligibility criteria:
inclusion criteria: * breast cancer with evidence of unresectable, locally recurrent, or metastatic disease. * tumors over-expressing her-2 * candidate for treatment with docetaxel/trastuzumab exclusion criteria: * histology of inflammatory carcinoma * ast and/or alt \>1.5 x uln concomitant with alp \>2.5 x uln

Keywords: breast cancer over-expressing her2. first-line treatment with sunitinib/docetaxel/trastuzumab.
immediate implant with no graft , autogenous graft or xenograft.

Conditions: Dental Diseases

Summary: immediate implant placement with no graft , autogenous graft or xenograft with provisionalization.

immediate implant placement in maxillary esthetic zone without augmenting the jumping gap versus the use of autogenous bone particulates or demineralized bovine bone graft (randomized clinical trial)

Eligibility criteria:
inclusion criteria: * patients with non-restorable teeth exclusion criteria: * intra oral pathology and systemic conditions that contraindicate dental implants.
today2 phase 2 follow-up

Conditions: Type 2 Diabetes

Summary: the primary objective of t2p2 is to track the progression of t2d and related comorbidities and complications in the today cohort as they transition to young adulthood. we hypothesize that: * youth-onset type 2 diabetes (t2d) will progress rapidly and result in high rates of diabetes-related medical complications and comorbidities. * the rapid rate of progression is related to increased insulin resistance characteristic of puberty, worse β-cell function, degree of glycemic control, control of non-glycemic factors, and obesity itself.


Eligibility criteria:
inclusion criteria: * participated in today clinical trial. exclusion criteria: -

Keywords: youth onset type 2 diabetes insulin sensitivity beta cell function macrovascular comorbidities microvascular comorbidities
predictors associated with seeking orthodontic treatment, compliance and treatment success

Conditions: Malocclusion, Angle Class II

Summary: aim: to search for reasons for seeking orthodontic treatment, compliance during orthodontic treatment, drop-out from orthodontic treatment and success of orthodontic treatment. methods: evaluation before, during and at the end of orthodontic treatment. clinical and diagnostic evaluation of complexity before and at the end of orthodontic treatment, evaluation of awareness of treatment need, impact on social and psychological aspects, functional disturbances, impact of malocclusion on quality of life, social interaction, ability to perform daily activities.

data will include diagnostic measurements on study casts, x-rays, and data from questionnaires given to children and parents. statistical analyses will explore predictors of treatment success with treatment need, compliance and psycho-social domains.

Eligibility criteria:
inclusion criteria: * distal molar occlusion, overjet \>5 mm, cervical vertebral maturation method stages (cs) -cs2, cs3 or cs4 exclusion criteria: * mental retardation

Keywords: quality of life
tumor lysate pulsed-dendritic cell vaccines after high-dose chemotherapy for non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: when patients relapse after primary chemotherapy for non-hodgkin's lymphoma, they may be eligible to receive high-dose chemotherapy with autologous stem cell support. unfortunately high-dose chemotherapy is curative in less than half the patients who receive it. this study is being conducted to determine the safety, side effects, and the ability to respond to an investigational vaccine that consists of tumor-pulsed dendritic cells given with an immune stimulating drug called interleukin-2. the patient must have a lymphomatous node accessible for excision to prepare the vaccine. dendritic cells are immune cells that are obtained from the blood, and are important in the body's immune response to foreign substances. this study will examine the response of the immune system after three vaccinations (composed of dendritic cells, which have been exposed to dead fragments of lymphoma cells) given beginning three months after transplant. vaccination may result in sensitizing the patient's dendritic cells to his lymphoma cells, potentially resulting in an immune response against the lymphoma. twelve patients will be treated on study.


Eligibility criteria:
inclusion criteria: * histologically documented, aggressive and/or intermediate grade nhl, b-cell and t-cell. * in relapse after first-line conventional chemotherapy. primary therapy should include a doxorubicin-based regimen. * patients must have disease sensitive to induction chemotherapy, radiation therapy, and/or radioimmunotherapy. successful treatment of cns or meningeal disease is allowed. * patients must have accessible tumor for biopsy or excision. * cumulative total doxorubicin: \<500 mg/m2 * performance score 0-2 * no prior pelvic rt * patients with a prior malignancy are eligible if they were treated for cure and have no evidence of active disease. * patients may not be taking immunosuppressive agents. * informed consent; irb approval

Keywords: dendritic cells
brazilian reality in the diagnosis and treatment of diffuse large b cell lymphoma - bra-dlbcl

Conditions: Diffuse Large B Cell Lymphoma

Summary: national, multicenter, non-randomized, retrospective observational study (real world evidence-rwe) to analyze the epidemiological profile of diffuse large b cell lymphoma, clinical management, treatment in molecular subgroups, progression profile and patient survival outcomes enrolled and treated within the last 6 years (2017 to 2022), in national cancer reference centers.

diffuse large b-cell lymphoma management is a challenge in clinical setting, as the heterogeneity of conditions due to the molecular complexity of dlbcl may limit treatment response. other major factor is that in brazil we lack evidence of treatment response profiling regarding this molecular complexity. to know the epidemiological profile of dlbcl, together with the first-line treatment profile that has been adopted in reference centers, as well as the management of relapsing, is essentially important in generating evidence that add up to actions targeting the improvement of patient care, providing them with better treatments. the brazilian reality of clinical presentation, management profile, employed treatments and response rate is little known. considering the brazilian reality of a continental country, where healthcare services in reference centers present heterogeneous realities, analyzing clinical routine data may generate important evidence (rwe) to comprise the understanding on treatments effectiveness. generated evidence has the potential to help understanding the reality of brazilian patients, as well as supporting new regional researches.

Eligibility criteria:
inclusion criteria: * male and female; * age above 18 years old; * diagnosis of diffuse large b-cell lymphoma (dlbcl) and high-grade non-hodgkin b-cell lymphoma at all stagings; * lymphoma classified for the cell of origin (gcb - germinal center b-cell lymphoma, and non-germinal center); * having first life of treatment information available in institutional medical record; * having survival data available in institutional medical record. exclusion criteria: * no medical record of the molecular subgroup classification; * diagnosis of diffuse large b-cell lymphoma, confirmed in the year 2016; * patients diagnosed with transformed lymphomas.

Keywords: lymphoma; rwe; diffuse large b cell
a dose finding study to assess efficacy and safety of ibi128 in chinese gout subjects

Conditions: Gout; Hyperuricemia

Summary: ibi128 (tigulixostat) is a novel non-purine selective inhibitor of xanthine oxidase (xo). the xo inhibitors lower uric acid concentrations in serum by inhibiting the production of uric acid. this ia a randomized, open label, multicenter, parallel-group, positive-controlled, dose finding, and phase ii study to assess efficacy and safety of ibi128 in chinese gout subjects.


Eligibility criteria:
inclusion criteria: 1. participants must be aged between 18 and 75 years old (inclusive, as of the time of signing the informed consent form), with no gender restrictions; 2. body mass index (bmi) should fall within the range of 18.0 to 40.0 kg/m² (including both ends of the range); 3. subjects must meet the 2015 acr/eular classification criteria for the diagnosis of gout (refer to appendix 4); 4. at the screening stage, subjects must have a blood uric acid level of ≥480 μmol/l; 5. subjects must voluntarily sign the informed consent form and agree to strictly adhere to the requirements outlined in this protocol. exclusion criteria (brief): 1. history of allergy to any component of tigulixostat; 2. previous allergy or intolerance to febuxostat; 3. subjects who have taken uric acid lowering medications within 2 weeks prior to screening; 4. subjects who experienced an acute gout flare-up within 4 weeks prior to screening or immediately before the first dose administration; 5. subjects considered to have secondary gout (elevated serum uric acid due to causes other than renal insufficiency); 6. subjects with a history of xanthinuria.
electrical stimulation combined with motor training on eeg-emg coherence and motor function in individuals with stroke

Conditions: Stroke

Summary: this study investigated whether electrical stimulation (es) prior to a hand function training session for a total of eight weeks can better improve neuromuscular control and hand function in subacute stroke individuals and change electroencephalography-electromyography (eeg-emg) coherence, as compared to the control (sham es).

subjects were randomly assigned into es and control groups. both groups received 20-minute hand function training twice a week, and the es group received 40-minute es on the median nerve of the affected side before each training session. the control group received sham es - electrodes were placed on the same location but no electric current was applied. eeg, emg and fugl-meyer assessment (fma) were collected before, at the 4th week, at the end of 8th week, and 4 weeks after the end of intervention.

Eligibility criteria:
inclusion criteria: 1. first-ever cerebral cortical region involved chronic stroke, onset over a month, 2. able to perform active thumb flexion on the affected side with the scores of manual muscle test at least two points, and 3. at stable medical condition for intervention exclusion criteria: 1. history of other neurological disorders, 2. cognitive impairment (mini-mental state examination score \<24, mmse),26 3. unable to follow orders, 4. contraindications of es, and 5. under 20 years old

Keywords: electrical stimulation
observational study of effectiveness and tolerability of gliclazide mr 60mg in diabetic patients fasting during ramadan

Conditions: Type 2 Diabetes

Summary: the purpose of this observational study is to assess effectiveness and tolerability of gliclazide mr 60mg during ramadan in a real world setting in 9 countries from asia pacific and middle east/north africa


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities * male or female type 2 diabetic patients aged \>18 years * patients with controlled or suboptimal controlled type 2 diabetes * patients with experience in smbg controlling using glucometer * patients who are willing to fast during ramadan * patients already treated with gliclazide mr 60mg exclusion criteria: * insulin therapy requirement * severe liver or renal failure * hba1c ≥ 9% * contraindication to gliclazide according to smpc * pregnancy or breast feeding * previous experience of severe or repeated hypoglycemia events without triggered factor within the previous year
comparison of post-discharge growth of premature infants using two different formulas

Conditions: Premature Birth of Newborn

Summary: the objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.

infants will be randomized upon discharge from the nicu. we will follow weight, height and head circumference for three months following discharge, in addition any feeding difficulties will be noted.

Eligibility criteria:
inclusion criteria: 1. preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed). 2. gestational week 30-34. exclusion criteria: 1. congenital major malformation (e.g. congenital heart disease). 2. chromosomal abnormality (e.g. down's syndrome) 3. gastrointestinal morbidity: s/p abdominal surgery, s/p nec 4. milk allergy 5. chronic disease (e.g. oxygen treatment)

Keywords: premature neonate post-discharge formula
monitoring the hyperammonaemia:toxicity of drugs (ammotox)

Conditions: Hyperammonemia; Metabolic Disease; Adverse Drug Event; Drug Toxicity

Summary: several drugs and chemotherapies seem to have an impact on the metabolic system. this study investigates reports of metabolic toxicities such as hyperammonemia, including the international classification of disease icd-10 for treatments in the world health organization (who) global individual case safety report (icsr) database (vigibase).

several drugs and chemotherapies seem to have an impact on the metabolic system and are responsible of a wide range of metabolical side effects such as hyperammonemia. those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. this study investigates the main characteristics of patients affected by metabolic side effects imputed to drugs in particular hyperammonemia. a causality assessment according to the who-umc (world health organization - uppsala monitoring center) is systematically applied.

Eligibility criteria:
inclusion criteria: * case reported in the who's pharmacovigilance database till 01/05/2019 exclusion criteria: * chronology not compatible between the drug and the toxicity
comparing operative, postoperative and quality of life of patients after salvage and radical cystectomy

Conditions: Urinary Bladder Cancer

Summary: to compare operative difficulties, type of urinary diversion, intraoperative \& postoperative complications and quality of life in patients underwent radical cystectomy and those after salvage cystectomy.

radical cystectomy is the standard treatment for muscle-invasive bladder cancer. however, in well selected patients, bladder preservation with radiotherapy and chemotherapy with maximal transurethral resection of bladder tumor (turbt) is done. nowadays, multiple guidelines support the use of bladder sparing therapy (bst) in the form of a trimodal therapy (tmt) as an alternative to primary rc with curative intent for selected, well-informed and compliant patients, who desire to retain their bladder. patients usually would prefer a bst, as it is considered tolerable due to its minimal invasiveness with genuinely manageable toxicity. however, a significant proportion of patients may eventually need a salvage radical cystectomy (sv-rc) due to non-response to bst or local recurrence. salvage cystectomy post-trimodality therapy for intravesical recurrence has an intraoperative and early complication rate comparable to primary cystectomy, salvage cystectomy post-trimodality therapy is associated with a higher risk of overall and major late complications than primary cystectomy, irradiated tissue presents technical and surgical challenges, as radiation can lead to an overexpression of cytokines which causes uncontrolled matrix proliferation and fibrosis these post-radiation changes lead to fixation of pelvic organs, making blunt dissection more difficult, as well as causing disruption of surgical landmarks and loss of tissue planes another consequence of irradiated tissue is that healing is impaired and tissue is weakened, leading to the potential for wound breakdown and fistula formation.

Eligibility criteria:
inclusion criteria: * patients with muscle invasive bladder cancer ≥ ct2n0/xm0 who underwent salvage cystectomy / going for bladder preservation protocol. * patients with muscle invasive bladder cancer underwent radical cystectomy. exclusion criteria: * patients refusing to participate in our study. * patients with metastatic bladder cancer

Keywords: salvage radical
adenovirus initiative study in epidemiology in france

Conditions: Viral Conjunctivitis

Summary: the objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. this epidemiological study will include approximately 500 patients in france. the planned duration of the study is one year from the first patient visit to the last patient visit.

Eligibility criteria:
inclusion criteria: * male or female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms. * patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data. * no history of hypersensitivity to corn starch, talcum powder or dacron (sampling fleece components). exclusion criteria: * current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result. * previous enrolment in the present study. * any direct involvement with the study conduct at site or any family link with study site staff.

Keywords: adenoviral conjunctivitis diagnosed with adenoplus™ test
a comparison of sequential compression devices and foot pumps in the obstetric population

Conditions: Thrombophilia

Summary: the researchers at johns hopkins university believe that the foot pump will be superior to sequential compression devices in comfort and patient compliance which may increase provider efforts to prevent deep vein thrombosis (dvt) in pregnancy.

the investigators will be comparing sequential compression devices (scds) to foot pumps to determine if foot pumps will be better tolerated by obstetric patients, both antepartum and intrapartum. patients in whom thromboembolic prophylaxis is deemed necessary and ordered by the treating physician, who agree to participate in the study will be randomly assigned to receive scds or the foot pump as part of their thromboembolic prophylaxis regimen. the investigators will administer a questionnaire to assess patients' satisfaction and comfort with each device and they will be asked to complete a log of hours they wore their assigned device for a 7 day period (or as long as they are prescribed). random spot checks to verify compliance will be performed.

Eligibility criteria:
inclusion criteria: * pregnant * bedrest * thrombophilia * prescribed dvt prophylaxis exclusion criteria: * active dvt

Keywords: deep vein thrombosis thrombophilia pregnancy thromboprophylaxis decreased mobility hospitalization